Study Protocol for Multi-Center, Open-Label, Randomized Controlled Trial for Assessing the Efficacy and Safety of Electroacupuncture for Cold Hypersensitivity in Hands and Feet

Abstract Background: Cold hypersensitivity in the hands and feet (CHHF) is defined as the symptom of a sensation of coldness in the extremities under conditions that are not considered cold by an unaffected person. CHHF is common in East Asian women. CHHF can affect the quality of life by placing restrictions on one's daily activities. Although electroacupuncture (EA) and acupuncture have been widely used for treating CHHF, randomized clinical trial (RCT) has not yet been conducted for evaluating the safety and efficacy of EA or acupuncture for the treatment of CHHF. This study aims to evaluate the effects of EA in CHHF patients. Methods: This study is a randomized, multicenter, and parallel design clinical trial. Overall, 72 participants will be randomly assigned to the EA treatment group, acupuncture treatment group, and untreated control group in 1:1:1 ratio via a web-based randomization system. The EA treatment group and acupuncture treatment group will receive EA or acupuncture treatment by visiting ten times at intervals of twice a week for five weeks. Follow-up visits will be made four weeks after the end of treatment. For the untreated control group, three visits will be made. The primary outcome measures will be the CHHF visual analogue scale score. Secondary outcome measures will be the body temperature of hands and feet, total scores of the Korean version of the World Health Organization Quality of Life Scale abbreviated version, the results of the questionnaire of health-related quality of life, questionnaire of demonstration, and questionnaire of cold hypersensitivity.Discussion: This study will be the first clinical trial to evaluate the efficacy and safety of EA for the treatment of CHHF. We expect this study to provide basic evidence for the treatment of CHHF with EA, future large-scale RCT, and the development of general clinical guidelines for CHHF in the Korean medical field.Trial registration: CRIS, KCT0004306. Registered on October 14, 2019. https://cris.nih.go.kr/cris/search/search_result_st01.jsp?seq=14865

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The efficacy and safety of Sipjeondaebo-tang in Korean patients with cold hypersensitivity in the hands and feet: A protocol for a pilot, randomized, double-blind, placebo-controlled, parallel-group clinical trial

10.21203/rs.2.223/v1 ◽

2019 ◽

Author(s):

Youme Ko ◽

Seung-Ho Sun ◽

In-Sik Han ◽

Ho-Yeon Go ◽

Tae-Hun Kim ◽

...

Keyword(s):

Quality Of Life ◽

Clinical Trial ◽

Herbal Medicine ◽

Randomized Clinical Trial ◽

Efficacy And Safety ◽

Double Blind ◽

Parallel Group ◽

Hands And Feet ◽

Cold Hypersensitivity

Abstract Background: Cold hypersensitivity in the hands and feet (CHHF) is frequent in Asian countries including Korea. The quality of life can be degraded by the symptoms of CHHF. In particular, gynecological disorders such as menstrual pain, infertility, leucorrhea, and irregular bleeding may be related to CHHF. Sipjeondaebo-tang(SDT) is widely used in the treatment of various diseases including CHHF by balancing Yin and Yang, restoring the deterioration of physiological function, and improving immunity. However, the efficacy of SDT in the treatment of CHHF has not been assessed in clinical trials. Therefore, we aimed to investigate the feasibility of a full randomized clinical trial of SDT for the treatment of CHHF in Korean women through this trial. Methods: This study will be a pilot, randomized, double-blind, two-arm, placebo-controlled, parallel-group, multicenter clinical trial. Women aged 19-59 years who present with CHHF will be recruited from five university hospitals. A total of 60 subjects will be randomly assigned to a treatment group (SDT) or a placebo group at a 1:1 ratio. The subjects will receive 3 g of either SDT or placebo three times daily for 8 weeks. The primary outcome measures will be the Visual Analogue Scale scores of CHHF. The secondary outcome measures will be changes in body temperature in both the hands and the feet as measured by using a thermometer and the Korean version of the World Health Organization Quality of Life Scale Abbreviated Version. Discussion: This will be the first trial to investigate the efficacy and safety of SDT in the treatment of CHHF. This study will provide basic clinical information regarding Korean herbal medicine treatment of CHHF and a clinical basis for designing a full randomized clinical trial. Trial registration: This study is registered at ClinicalTrials.gov, ID: NCT03374345. Registered on (15 February 2018). Keywords: Herbal medicine, Cold Hypersensitivity, Sipjeondaebo-tang, Cold intolerance.

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The efficacy and safety of Sipjeondaebo-tang in Korean patients with cold hypersensitivity in the hands and feet: A protocol for a pilot, randomized, double-blind, placebo-controlled, parallel-group clinical trial

10.21203/rs.2.223/v2 ◽

2019 ◽

Author(s):

Youme Ko ◽

Seung-Ho Sun ◽

In-Sik Han ◽

Ho-Yeon Go ◽

Tae-Hun Kim ◽

...

Keyword(s):

Quality Of Life ◽

Clinical Trial ◽

Randomized Clinical Trial ◽

Outcome Measures ◽

Efficacy And Safety ◽

Double Blind ◽

Parallel Group ◽

Hands And Feet ◽

Cold Hypersensitivity

Abstract Background Cold hypersensitivity in the hands and feet (CHHF) is frequent in Asian countries including Korea. The quality of life can be degraded by the symptoms of CHHF. In particular, gynecological disorders such as menstrual pain, infertility, leucorrhea, and irregular bleeding may be related to CHHF. Sipjeondaebo-tang(SDT) is widely used in the treatment of various diseases including CHHF by balancing Yin and Yang, restoring the deterioration of physiological function, and improving immunity. However, the efficacy of SDT in the treatment of CHHF has not been assessed in clinical trials. Therefore, we aimed to investigate the feasibility of a full randomized clinical trial of SDT for the treatment of CHHF in Korean women through this trial. Methods This study will be a pilot, randomized, double-blind, two-arm, placebo-controlled, parallel-group, multicenter clinical trial. Women aged 19-59 years who present with CHHF will be recruited from five university hospitals. A total of 60 subjects will be randomly assigned to a treatment group (SDT) or a placebo group at a 1:1 ratio. The subjects will receive 3 g of either SDT or placebo three times daily for 8 weeks. The primary outcome measures will be the Visual Analogue Scale scores of CHHF. The secondary outcome measures will be changes in body temperature in both the hands and the feet as measured by using a thermometer and the Korean version of the World Health Organization Quality of Life Scale Abbreviated Version. Discussion This will be the first trial to investigate the efficacy and safety of SDT in the treatment of CHHF. This study will provide basic clinical information regarding Korean herbal medicine treatment of CHHF and a clinical basis for designing a full randomized clinical trial.

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The Efficacy and Safety of Acupuncture for Prophylaxis of Vestibular Migraine: A Study Protocol for a Randomized Controlled Trial

Frontiers in Neurology ◽

10.3389/fneur.2021.709803 ◽

2021 ◽

Vol 12 ◽

Author(s):

Tianye Hu ◽

Hantong Hu ◽

Feng Chen ◽

Bin Jiang ◽

Fengfei Shen ◽

...

Keyword(s):

Quality Of Life ◽

Clinical Trial ◽

Outcome Measures ◽

Vestibular Migraine ◽

Secondary Outcome ◽

Control Group ◽

Controlled Clinical Trial ◽

Efficacy And Safety ◽

Randomized Controlled

Introduction: With a high incidence rate and low diagnosis rate, vestibular migraine (VM) can seriously affect the quality of life of patients, but it remains difficult to manage by current treatment options. Acupuncture may be a potential treatment option for VM prophylaxis, but the currently available evidence is still uncertain. Therefore, this trial aims to evaluate the efficacy and safety of acupuncture for VM prophylaxis.Methods: This is a 28-week parallel, randomized, controlled clinical trial including 4 weeks of baseline, 8 weeks of treatment, and 16 weeks of follow-up. A total of 72 participants will be randomly assigned to two groups. The participants will receive acupuncture in the experimental group, while the participants in the control group will be treated with venlafaxine. The primary outcome measures are change in vertigo/migraine days and vertigo/migraine attacks, vertigo severity, and migraine intensity per 4 weeks from baseline. The secondary outcome measures are change in doses of rescue medication, anxiety level, depression level, and quality of life per 4 weeks from baseline. Adverse events will be recorded for safety evaluation.Discussion: This study will investigate the efficacy and safety of acupuncture for VM prophylaxis. The results will contribute to determining whether acupuncture can serve as an optional treatment strategy for treating VM.Clinical Trial Registration:www.ClinicalTrials.gov, identifier: NCT0464088.

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PENGARUH PEMBERIAN INHALASI KOMBINASI SALMETEROL/FLUTIKASON PROPIONAT TERHADAP KUALITAS HIDUP PENDERITA PENYAKIT PARU OBSTRUKTIF KNONIK STABIL

Jurnal Penelitian Kesmasy ◽

10.36656/jpksy.v1i2.155 ◽

2019 ◽

Vol 1 (2) ◽

pp. 28-33

Author(s):

Refi Sulistiasari

Keyword(s):

Quality Of Life ◽

Clinical Trial ◽

Treatment Group ◽

Control Group ◽

Copd Assessment Test ◽

Copd Patients ◽

Significant Difference ◽

Inhaled Therapy ◽

St George's Respiratory Questionnaire

It is known that inflammation is the underlying cause of COPD, and this affects to quality of life of the patient. Provision of inhaled therapy combination of LABA and corticosteroids is one of therapy in pharmacology of stable PPOK patients. The aim of this study was to know the benefits of inhalation of 50 g / fluticasone propionate 500 g inhibition in stable COPD patients. The research design is clinical trial. The study was conducted for 3 months and was performed on 26 stable COPD patients divided into two groups: 15 patients for the treatment group and 15 patients for the control group. After the measurements were obtained, there was a significant difference in the quality of life as measured by St. George's Respiratory Questionnaire (SGRQ) (p = 0.001) and COPD Assessment Test (CAT) (0.001) measurements were made twice on the first and thirtieth days.

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A Multicentre Randomized Clinical Trial on Efficacy and Safety of Huxin Formula in Patients Undergoing Percutaneous Coronary Intervention

Evidence-based Complementary and Alternative Medicine ◽

10.1155/2014/143064 ◽

2014 ◽

Vol 2014 ◽

pp. 1-7 ◽

Cited By ~ 1

Author(s):

Huan-Lin Wu ◽

Yun-Fei Wang ◽

Jun-Zhe Li ◽

Min-Zhou Zhang ◽

Xiao-Gang Sheng ◽

...

Keyword(s):

Quality Of Life ◽

Clinical Trial ◽

Percutaneous Coronary Intervention ◽

Treatment Group ◽

Coronary Intervention ◽

Control Group ◽

Percutaneous Coronary ◽

Quality Of Life Scale ◽

Life Scale

Percutaneous coronary intervention (PCI) is widely used in clinical treatment of coronary artery disease. However, the effects of PCI on preventing restenosis after revascularization and improving the quality of life were not satisfying. Huxin Formula is formulated by modifying an experienced Chinese medicine formula and has been widely used in clinical practice due to its marked effects on coronary heart disease. A multicentre double-blind randomized controlled clinical trial was designed to evaluate the effects and safety of Huxin Formula in patients undergoing PCI. Our results showed that there was no significant difference between the two groups in main outcomes. For patients with ejection fraction (EF)>50%, score of the quality of life scale was higher in treatment group compared with control group. For patients with unstable angina, score of the quality of life scale in 360 days was significantly higher in treatment group compared with control group (P<0.05). No obvious adverse reaction was found in the use of Huxin Formula. In conclusion, Huxin Formula, believed to be a safe treatment for patients after PCI, has benefits in improving the quality of life in patients with unstable angina though it failed to show superiority in primary and secondary outcomes.

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PENGARUH PEMBERIAN INHALASI KOMBINASI SALMETEROL/FLUTIKASON PROPIONAT TERHADAP KUALITAS HIDUP PENDERITA PENYAKIT PARU OBSTRUKTIF KNONIK STABIL

Jurnal Penelitian Kesmasy ◽

10.36656/jpksy.v1i2.88 ◽

2019 ◽

Vol 1 (2) ◽

pp. 28-33

Author(s):

Refi Sulistiasari

Keyword(s):

Quality Of Life ◽

Clinical Trial ◽

Treatment Group ◽

Control Group ◽

Copd Assessment Test ◽

Copd Patients ◽

Significant Difference ◽

Inhaled Therapy ◽

St George's Respiratory Questionnaire

It is known that inflammation is the underlying cause of COPD, and this affects to quality of life of the patient. Provision of inhaled therapy combination of LABA and corticosteroids is one of therapy in pharmacology of stable PPOK patients. The aim of this study was to know the benefits of inhalation of 50 mg / fluticasone propionate 500 mg inhibition in stable COPD patients. The research design is clinical trial. The study was conducted for 3 months and was performed on 26 stable COPD patients divided into two groups: 15 patients for the treatment group and 15 patients for the control group. After the measurements were obtained, there was a significant difference in the quality of life as measured by St. George's Respiratory Questionnaire (SGRQ) (p = 0.001) and COPD Assessment Test (CAT) (0.001) measurements were made twice on the first and thirtieth days.

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Efficacy and Safety of the Two Ayurveda Drug Regimens in Uterine Fibroids: A Randomized Single-Blind Clinical Trial

Evidence-based Complementary and Alternative Medicine ◽

10.1155/2021/4325502 ◽

2021 ◽

Vol 2021 ◽

pp. 1-8

Author(s):

K. P. K. R. Karunagoda ◽

P. K. Perera ◽

H. Senanayake ◽

S. De Silva Weliange

Keyword(s):

Quality Of Life ◽

Clinical Trial ◽

Uterine Fibroids ◽

Mean Value ◽

Control Group ◽

Efficacy And Safety ◽

Drug Regimens ◽

Single Blind

This study aims to assess the efficacy and safety of two Ayurveda drug regimens for the treatment of uterine fibroids (UF) in a randomized single-blind clinical trial. 120 participants with UF (volume ≥ 2 cm3) were randomly allocated at a 1 : 1 : 1 ratio to 2 experimental groups and the control group. The 12-week intervention period was followed by 12-week follow-up. The primary efficacy endpoint was the change of the largest UF volume. The secondary efficacy endpoints were assessed by the pictorial bleeding assessment score (PBAC), UF symptoms, and quality of life score. The safety endpoints were changed in hepatic and renal safety parameters and patients experiencing adverse effects. Significant decrease was observed in the volume of UF in the arm II but not in arm I, while a significant increase was observed in the volume of the largest UF in the control group at 12th week. The PBAC score remained stable in all groups. Further mean value of the intervention arms symptom severity subscale (SSS) was significantly reduced compared to the control arm. Health-related quality of life (HRQL) value improved in 12th week of both experimental arms compared to baseline. Control arm HRQL value was reduced compared to baseline. The volume of the largest UF and both SSS and HRQL values remained stable within the follow-up period in the tested arms. The findings of this study demonstrated the safety and efficacy of selected two Ayurveda drug regimens in reducing the volume of UF and related symptoms and improving quality of life.

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Efficacy and Safety of a Novel Herbal Medicine in the Treatment of Irritable Bowel Syndrome: A Randomized Double-Blinded Clinical Trial

Gastroenterology Research and Practice ◽

10.1155/2020/8213082 ◽

2020 ◽

Vol 2020 ◽

pp. 1-11

Author(s):

Ghasem Bordbar ◽

Mohammad Bagher Miri ◽

Mahmoud Omidi ◽

Saeed Shoja ◽

Malihe Akhavan

Keyword(s):

Quality Of Life ◽

Clinical Trial ◽

Irritable Bowel Syndrome ◽

Herbal Medicine ◽

Essential Oils ◽

Herbal Remedies ◽

Control Group ◽

Efficacy And Safety ◽

Irritable Bowel

Background. The unresponsiveness to conventional pharmacological treatments and their side effects have led patients with irritable bowel syndrome (IBS) to use complementary and alternative medicine such as herbal remedies. Beside, Zataria multiflora Boiss (ZM), Trachyspermum ammi L. (TA), and Anethum graveolens L. (AG) are being used as an antiseptic, carminative, and antispasmodic in traditional medicine. This trial investigated the efficacy and safety of a combination of ZM, AG, and TA essential oils in the treatment of IBS. Method. The present study was a randomized double-blind clinical trial with parallel groups in Iran. Patients in the control arm received three tablets of 10 mg hyoscine butylbromide daily for two weeks, and the intervention arm was daily treated with two 250 mg softgel capsules containing 180 mg of essential oils of ZM, AG, and TA for two weeks. Primary outcomes were the response rates based on the IBS Symptom Severity Scale (IBS-SSS), IBS Adequate Relief (IBS-AR), and IBS Global Assessment Improvement (IBS-GAI) at the end and two weeks after the end of the intervention. Secondary outcomes were the improvement rates in IBS-SSS scores, improving the quality of life, safety, and tolerability. Results. The posttreatment improvement percentage based on IBS-AR, IBS-GAI, and IBS-SSS scales was 83.9%, 75%, and 87% in the intervention group and 37.9%, 27.5%, and 34.4% in the control group, respectively (P<0.001). Also, the improvement of the quality of life in the herbal medicine arm was significantly more than that in the control arm (P<0.001). Conclusions. According to the results, the herbal medicine investigated in this study can be considered an appropriate alternative treatment for IBS.

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Impact and cost-effectiveness evaluation of a community-based rehabilitation intervention on quality of life among Chinese adults with hearing loss: study protocol for a randomized controlled trial

Trials ◽

10.1186/s13063-021-05228-2 ◽

2021 ◽

Vol 22 (1) ◽

Author(s):

Xin Ye ◽

Dawei Zhu ◽

Siyuan Chen ◽

Xuefeng Shi ◽

Rui Gong ◽

...

Keyword(s):

Quality Of Life ◽

Hearing Loss ◽

Cost Effectiveness ◽

Treatment Group ◽

Hearing Aids ◽

Control Group ◽

Chinese Adults ◽

Community Based ◽

The Impact

Abstract Background Hearing loss is quite prevalent and can be related to people’s quality of life. To our knowledge, there are limited studies assessing the efficacy of hearing interventions on quality of life in adults. Therefore, we aim to conduct a randomized controlled trial (RCT) to determine the impact and cost-effectiveness of community-based hearing rehabilitation on quality of life among Chinese adults with hearing loss. Methods/design In this two-arm feasibility study, participants aged 16 and above with some degree of hearing loss (n = 464) will be recruited from Linyi City, Shandong Province. They are randomly assigned to the treatment group or the control group. Those in the treatment group are prescribed with hearing aids, while those in the control group receive no intervention. Reinstruction in use of devices is provided for the treatment group during booster visits held 12 months post-randomization or unscheduled interim visits when necessary. Data are collected at baseline and the follow-up 20 months later. The primary outcome is changes in quality of life over a 20-month study period. Secondary outcomes include sub-dimensions in quality of life, physical functioning, chronic diseases, cognitive function, depression, social support, hospitalizations, falls, and healthcare costs. Finally, we will evaluate whether hearing aids intervention is cost-effective to apply in a large scale. Discussion The trial is designed to evaluate the impact and cost-effectiveness of a community-based rehabilitation intervention on quality of life among Chinese adults with hearing loss. We hope that it would help improve the well-being for Chinese adults and provide references in policy and practice for China and other countries. Trial registration Chinese Clinical Trial Registry ChiCTR1900024739. Registered on 26 July 2019.

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Effect of Baduanjin exercise intervention on cognitive function and quality of life in women with breast cancer receiving chemotherapy: study protocol of a randomized controlled trial

Trials ◽

10.1186/s13063-021-05355-w ◽

2021 ◽

Vol 22 (1) ◽

Author(s):

Xiao-Lin Wei ◽

Ru-Zhen Yuan ◽

Yong-Mei Jin ◽

Shu Li ◽

Ming-Yue Wang ◽

...

Keyword(s):

Breast Cancer ◽

Quality Of Life ◽

Clinical Trial ◽

Cognitive Function ◽

Exercise Intervention ◽

Early Stage ◽

Early Stage Breast Cancer ◽

Pharmacological Intervention ◽

Control Group

Abstract Background More than 50% cognitive impairment was reported by cancer patients before and after medical treatment. However, there are no effective interventions to manage the cognitive problem in women with breast cancer. This pilot study was designed to evaluate the protective effect of Baduanjin exercise on cognitive function and cancer-related symptoms in women with early-stage breast cancer undergoing chemotherapy. Method A single-blinded, randomized control trial was designed. The trial will recruit 70 patients with early-stage breast cancer scheduled to receive chemotherapy from Shanghai in China. All participants will be randomly assigned to (1:1) the supervised Baduanjin group (5 times/week, 30 min each time) or the wait-list control group for 3 months. The effect of Baduanjin exercise intervention will be evaluated by outcome measures including subjective and objective cognitive function, symptoms (fatigue, depression, and anxiety), and health-related quality of life at pre-intervention (T0), 8 weeks (T1), and 12 weeks (T2). The PCI score in the FACT-Cog as the primary cognitive outcome will be reported descriptively, while effect sizes and 95% confidence intervals (CIs) will be calculated. The collected data will be analyzed by using an intention-to-treat principle and linear mixed-effects modeling. Discussion This is the first randomized clinical trial to investigate whether Baduanjin exercise will have a positive role in improving cognitive function in women with breast cancer receiving chemotherapy. If possible, Baduanjin exercise will be a potential non-pharmacological intervention to manage cognitive dysfunction and promote survivorship care among breast cancer survivors. Trial registration Chinese Clinical Trial Registry (ChiCTR) ChiCTR2000033152. Registered on 22 May 2020

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